Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Agitation in Patients With Dementia of the Alzheimer's Type Clinical Trial

Official title:

A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02446132
• Other study ID #: 15-AVP-786-303
• Secondary ID: 2017-002455-29
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: January 30, 2025

Study information

• Verified date: March 2024
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: Otsuka Call Center
• Phone: 844-687-8522
• Email: OtsukaRMReconciliation[@]rmpdc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, which also allows participants from the Phase 2 Study 12-AVR-131 to be included.

Description:

Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305.

Participants will be enrolled in the study for approximately 56 weeks (participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks).

Approximately 1200 participants will be enrolled at approximately 250 centers globally.

All participants enrolled will receive AVP-786; the treatment dose assigned will be masked to the participant, investigator, study staff, and the sponsor.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: January 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. (Note: A delay in enrollment may include delays associated with COVID-19 restrictions.)

• Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria

• Either out-patients or residents of an assisted-living facility or a skilled nursing home

• Participants who delay enrollment must have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline

• Participants who delay enrollment must have a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation

• Participants who delay enrollment must have a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of = 4 (moderately ill) at screening and baseline

• Participants who delay enrollment must have a Mini-Mental State Examination (MMSE) score between 6 and 26 (inclusive) at screening and baseline

Exclusion Criteria:

• Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)

• Participants determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator

• Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding baseline

Related Conditions & MeSH terms

• Agitation in Patients With Dementia of the Alzheimer's Type
• Alzheimer Disease
• Dementia
• Psychomotor Agitation

Intervention

Drug:
• AVP-786

Locations

Country	Name	City	State
Bulgaria	Center for Mental Health - Ruse	Ruse
Bulgaria	Medical Center Sveti Naum Site #707	Sofia
Bulgaria	Mental Health Centre Prof. Nikola Shipkovenski Site #713	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment Alexandrovska Site #704	Sofia
Bulgaria	Vrach and Sv. Sv. Kuzma and Damian Site #710	Sofia
Bulgaria	Medical Center Mladost-M	Varna
Bulgaria	Medica Plus Medical Center	Veliko Tarnovo
Canada	Dr. Alexander McIntyre Inc.	Penticton
Czechia	Fakultni Nemocnice u sv. Anny v Brne Site #722	Brno
Czechia	Fakultní Nemocnice Hradec Králové Site #724	Hradec Kralové
Czechia	NeuropsychiatrieHK Site #729	Hradec Kralové
Czechia	Brain-Soultherapy	Kladno
Czechia	Námestí národního odboje 692 Site #723	Kutna Hora
Czechia	A-Shine s.r.o. Site #731	Plzen
Czechia	AD71	Praha
Czechia	Clintrial	Praha
Czechia	Neurologicka Ambulance - Forbeli	Praha
Czechia	Neuropsychiatrie Site #726	Praha
Czechia	Vestra Clinics	Rychnov nad Knežnou
France	Centre Hospitalier Universitaire Dijon Bourgogn Site #536	Dijon Cedex
France	Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord Site #535	Saint-Etienne	Auvergne-Rhone-Alpes
France	Centre Hospitalier Universitaire Toulouse - Casselardit Ancely Site #533	Toulouse
Hungary	Dr. Kenessey Albert Kórház-Rendelointézet	Balassagyarmat
Hungary	Pszichiatriai es Pszichiatriai Rehabilitacios Osztaly Site #586	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz	Debrecen
Hungary	Dr. Mathe es Tarsa Beteti Tarsasag Site #593	Kalocsa
Hungary	PsychoTech Clinical Research Site# 580	Pécs
Italy	Azienda Ospedaliera Sant'Andrea Site #606	Roma
Italy	Fondazione Policlinico Tor Vergata Site #609	Roma
Italy	Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico	Roma
Poland	Ksiedza Hugona Kollataja 9	Bydgoszcz
Poland	Care Clinic Clinical Research Site #750	Katowice
Poland	Wielospecjalistyczna Poradnia Lekarska Synapsis Site #741	Katowice
Poland	Krakowska Akademia Neurologii Site #740	Kraków
Poland	Malopolskie Centrum Medyczne Site #747	Kraków
Poland	Medycyna Milorzab Site #743	Lodz
Poland	Solumed Centrum Medyczne Site #753	Poznan
Poland	Centrum Medyczne Euromedis	Szczecin
Poland	Centrum Medyczne NeuroProtect Site #742	Warszawa
Poland	ClinHouse Centrum Medyczne	Zabrze
South Africa	ACF Neurological Services	Cape Town
South Africa	Cape Trial Centre	Cape Town
South Africa	Flexivest Fourteen Research Centre	Cape Town
South Africa	Apollo Clinical Research Site #623	Johannesburg
South Africa	Medical and Dental Centre	Rosebank
Spain	Accellacare Alcobendas	Alcobendas
Spain	Fundació ACE	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital General Universitario de Elche	Elche
Spain	Hospital Universitario 12 de Octubre Site #657	Madrid
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Virgen Macarena Site #649	Sevilla
Spain	Complejo Asistencial de Zamora Hospital Virgen de la Concha	Zamora
Spain	Hospital Viamed Montecanal Site #643	Zaragoza
United States	Daystar Clinical Research Inc	Akron	Ohio
United States	Neurology and Neuroscience Associates, Inc.	Akron	Ohio
United States	Neurology of Central Florida Rsch Ctr Site #803	Altamonte Springs	Florida
United States	Dent Neurologic Institute	Amherst	New York
United States	Advanced Research Center, Inc. Site #835	Anaheim	California
United States	Emory Brain Health Center	Atlanta	Georgia
United States	NeuroTrials Research Inc	Atlanta	Georgia
United States	JEM Research Institute	Atlantis	Florida
United States	Negron Research Services / Humanity Clinical Research Site# 766	Aventura	Florida
United States	Insight Clinical Trials, LLC Site #570	Beachwood	Ohio
United States	Heritage Valley Medical Group, Inc.	Beaver	Pennsylvania
United States	Bedford VA Hospital	Bedford	Massachusetts
United States	Insight Neuroscience, LLC	Bellevue	Ohio
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Clinical Neuroscience Research Associates, Inc. dba The Memory Clinic	Bennington	Vermont
United States	Neurology Offices of South Florida	Boca Raton	Florida
United States	SFM Clinical Research, LLC Site #563	Boca Raton	Florida
United States	Bradenton Research Center Site #834	Bradenton	Florida
United States	Alzheimer Disease Center Site #804	Braintree	Massachusetts
United States	Clinical Research of Brandon	Brandon	Florida
United States	Clinical Research Of Brandon, LLC Site #838	Brandon	Florida
United States	Brooklyn Medical Institute	Brooklyn	New York
United States	Integrative Clinical Trials LLC #1	Brooklyn	New York
United States	Integrative Clinical Trials LLC #2	Brooklyn	New York
United States	Meridien Research	Brooksville	Florida
United States	Onyx Clinical Research, LLC	Caro	Michigan
United States	Valley Medical Research	Centerville	Ohio
United States	Valley Medical Research Site #788	Centerville	Ohio
United States	Brain and Spine Center	Chandler	Arizona
United States	MD First Research, LLC	Chandler	Arizona
United States	Herbert Harris, Md, Phd, Pa	Chapel Hill	North Carolina
United States	RH Johnson VA Medical Center	Charleston	South Carolina
United States	Roper St. Francis Healthcare	Charleston	South Carolina
United States	ANI Neurology PLLC dba Alzheimer's Memory Center	Charlotte	North Carolina
United States	Galen Research	Chesterfield	Missouri
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Ericksen Research and Development	Clinton	Utah
United States	Columbus Research & Wellness Institute, INC	Columbus	Georgia
United States	Medical Research & Health Education Foundation, Inc.	Columbus	Georgia
United States	The Ohio State University	Columbus	Ohio
United States	Neurology Clinic, P.C.	Cordova	Tennessee
United States	ATP Clinical Research, Inc. Site #763	Costa Mesa	California
United States	Millennium Psychiatric Associates, LLC	Creve Coeur	Missouri
United States	Connecticut Clinical Research	Cromwell	Connecticut
United States	Neurology Consultants of Dallas, PA	Dallas	Texas
United States	Texas Neurology, P.A.	Dallas	Texas
United States	University Texas Southwestern Medical Center	Dallas	Texas
United States	Associated Neurologists, PC	Danbury	Connecticut
United States	NeuroStudies. Net, LLC	Decatur	Georgia
United States	Quantum Laboratories, Inc.	Deerfield Beach	Florida
United States	Lytle and Weiss, PLLC dba Clinical Trials of the Rockies	Denver	Colorado
United States	InSite Clinical Research Site #576	DeSoto	Texas
United States	Moonshine Research Center, Inc	Doral	Florida
United States	Science Connections, LLC Site #814	Doral	Florida
United States	Duke University Medical Center	Durham	North Carolina
United States	Michigan State University Department of Neurology	East Lansing	Michigan
United States	Rhode Island Mood & Memory Research Institute	East Providence	Rhode Island
United States	The Samuel & Alexia Bratton Memory Clinic	Easton	Maryland
United States	Alexian Brothers Neurosciences Institute	Elk Grove Village	Illinois
United States	Core Clinical Research Site #772	Everett	Washington
United States	Health Initiatives Research	Fayetteville	Arkansas
United States	Clinical Research Solutions	Franklin	Tennessee
United States	University of Florida	Gainesville	Florida
United States	Behavioral Research Specialists, LLC	Glendale	California
United States	Finlay Medical Research Corp	Greenacres City	Florida
United States	Mir Neurology	Hagerstown	Maryland
United States	Geriatric and Adult Psychiatry LLC	Hamden	Connecticut
United States	Berma Research Group	Hialeah	Florida
United States	Direct Helpers Research Center	Hialeah	Florida
United States	Direct Helpers Research Center #801	Hialeah	Florida
United States	Galiz Research	Hialeah	Florida
United States	Indago Research & Health Center, Inc.	Hialeah	Florida
United States	Maxblue Institute	Hialeah	Florida
United States	New Life Medical Research Center, Inc.	Hialeah	Florida
United States	Reliable Clinical Research,LLC	Hialeah	Florida
United States	Research in Miami, Inc	Hialeah	Florida
United States	The Research Center, Inc	Hialeah	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Houston Methodist Neurological Institute	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Josephson Wallack Munshower Neurology, PC	Indianapolis	Indiana
United States	Irvine Center for Clinical Research	Irvine	California
United States	University of California, Irvine	Irvine	California
United States	University Hills Clinical Research	Irving	Texas
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Alphab Global Research #793	Jupiter	Florida
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	SIH Research, LLC	Kissimmee	Florida
United States	Omega Clinical Trials, LLC	La Habra	California
United States	Alzheimer's Research and Treatment Center #1	Lake Worth	Florida
United States	Alzheimer's Research and Treatment Center #2	Lake Worth	Florida
United States	Alzheimer's Research and Treatment Center #3	Lake Worth	Florida
United States	Meridien Research Site #558	Lakeland	Florida
United States	Cleveland Clinic Lou Ruvo Center for Brain Health at Lakewood Hospital	Lakewood	Ohio
United States	Sheenath Clinical Service Site #770	Lakewood	California
United States	Geriatric Solutions, LLC	Las Vegas	Nevada
United States	Innovative Clinical Research, Inc. Site #819	Lauderhill	Florida
United States	MidAmerica Neuroscience Research Foundation	Lenexa	Kansas
United States	The Birches at Newton / Family Medical Associates	Levittown	Pennsylvania
United States	Torrance Clinical Research Institute, Inc. Site #826	Lomita	California
United States	Alliance for Wellness, Inc dba Alliance for Research	Long Beach	California
United States	Collaborative Neuroscience Network, LLC.	Long Beach	California
United States	Neurology Associates of Arlington	Mansfield	Texas
United States	Flora Baker Center for Alzheimer's Disease and Related Disorders	Marmora	New Jersey
United States	Wellness Clinical Research Site #824	McKinney	Texas
United States	PRX Research Site #825	Mesquite	Texas
United States	Advance Medical Research Center #1	Miami	Florida
United States	Advance Medical Research Center #2	Miami	Florida
United States	Advanced Medical Center Group	Miami	Florida
United States	AMB Research Center, Inc.	Miami	Florida
United States	BioMed Research Institute	Miami	Florida
United States	CCM Clinical Research Group	Miami	Florida
United States	Central Miami Medical Institute	Miami	Florida
United States	Clinical Research Associates of South Florida #1	Miami	Florida
United States	Clinical Research Associates of South Florida #2	Miami	Florida
United States	Coral Research Clinic Corp	Miami	Florida
United States	Dade Research Center Llc	Miami	Florida
United States	Finlay Medical Research Corp Site #552	Miami	Florida
United States	First Class Medical Services Site #807	Miami	Florida
United States	Future Care Solution, LLC	Miami	Florida
United States	Global Medical Institutes, LLC	Miami	Florida
United States	Homestead Associates in Research Site# 797	Miami	Florida
United States	Hope Research Network LLC Site #773	Miami	Florida
United States	Innova Clinical Trials	Miami	Florida
United States	International Research Associates, LLC	Miami	Florida
United States	Kendall Research Institute	Miami	Florida
United States	Miami Dade Medical Research Institute, LLC	Miami	Florida
United States	Miami Jewish Health Systems, Inc.	Miami	Florida
United States	Nuovida Research Center Corp.	Miami	Florida
United States	Optimus U Corp	Miami	Florida
United States	P&S RESEARCH, LLC. Site #805	Miami	Florida
United States	Pharmax Research of South Florida	Miami	Florida
United States	Premier Clinical Research Institute, Inc. #1	Miami	Florida
United States	Premier Clinical Research Institute, Inc. #2	Miami	Florida
United States	Project 4 Research #1	Miami	Florida
United States	Project 4 Research #2	Miami	Florida
United States	Reliant Medical Research LLC Site #811	Miami	Florida
United States	Research Institute of West Kendall	Miami	Florida
United States	The Neurology Research Group, LLC	Miami	Florida
United States	United Health Research Corp. #1	Miami	Florida
United States	United Health Research Corp. #2	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Vitae Researrch Center LLC	Miami	Florida
United States	New Med Research, Inc Site #812	Miami Gardens	Florida
United States	Agility Clinical Research, Inc.	Miami Lakes	Florida
United States	NorthStar Medical Research Site #778	Middleburg Heights	Ohio
United States	The NeuroCognitive Institute	Mount Arlington	New Jersey
United States	Collier Neurologic Specialists, LLC	Naples	Florida
United States	Naples Research, Inc	Naples	Florida
United States	Coastal Connecticut Research, LLC	New London	Connecticut
United States	Bayside Clinical Research Site #556	New Port Richey	Florida
United States	Columbia University Medical Center	New York	New York
United States	Eastside Comprehensive Medical Center, LLC	New York	New York
United States	Manhattan Behavioral Medicine, PLLC	New York	New York
United States	Shankle Clinic	Newport Beach	California
United States	Boston Center for Memory	Newton	Massachusetts
United States	Sentara Neurosciences Institute	Norfolk	Virginia
United States	Lazlo J. Mate, MD, PA	North Palm Beach	Florida
United States	Research Center for Clinical Studies, Inc.	Norwalk	Connecticut
United States	Research Centers of America, LLC	Oakland Park	Florida
United States	Sensible Healthcare	Ocoee	Florida
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Oklahoma Clinical Research Center	Oklahoma City	Oklahoma
United States	NRC Research Institute	Orange	California
United States	Nathan S. Kline Institute for Psychiatric Research #1	Orangeburg	New York
United States	Nathan S. Kline Institute for Psychiatric Research #571	Orangeburg	New York
United States	Combined Research Orlando Site #799	Orlando	Florida
United States	Compass Research, LLC	Orlando	Florida
United States	Neurology Associates of Ormond Beach	Ormond Beach	Florida
United States	Four Rivers Clinical Research Inc.	Paducah	Kentucky
United States	IMIC Inc.	Palmetto Bay	Florida
United States	Innovation Medical Research Center	Palmetto Bay	Florida
United States	Innovation Medical Research Center Site #802	Palmetto Bay	Florida
United States	California Neurological Services	Panorama City	California
United States	Havana Research Institute	Pasadena	California
United States	Havana Research Institute Site 787	Pasadena	California
United States	Bronson Neurobehavioral Health	Paw Paw	Michigan
United States	University of West Florida	Pensacola	Florida
United States	Drexel University	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	NoesisPharma, LLC	Phoenix	Arizona
United States	Neurostudies Inc. Site#796	Port Charlotte	Florida
United States	Coastal Neurology, PA	Port Royal	South Carolina
United States	Alzheimer's Disease Center	Quincy	Massachusetts
United States	Psychiatry and Alzheimer's Care of Rochester, PLLC	Rochester	New York
United States	University of Rochester Medical Center	Rochester	New York
United States	Clinical Research Professionals	Saint Louis	Missouri
United States	PsychCare Consultants Research	Saint Louis	Missouri
United States	Suncoast Neuroscience Associates, Inc.	Saint Petersburg	Florida
United States	Veteran Affairs Medical Center, Salem Virginia	Salem	Virginia
United States	Pharmaceuticals Research Associates, Inc.	Salt Lake City	Utah
United States	Texas Medical Research Associates, L.L.C.	San Antonio	Texas
United States	Pacific Research Network, Inc. #1	San Diego	California
United States	Pacific Research Network, Inc. #2	San Diego	California
United States	VA San Diego Healthcare System	San Diego	California
United States	HB Clinical Trials Inc.	Santa Ana	California
United States	Syrentis Clinical Research	Santa Ana	California
United States	Roskamp Institute	Sarasota	Florida
United States	Behavioral Health Care Associates	Schaumburg	Illinois
United States	Perseverance Research Center, LLC	Scottsdale	Arizona
United States	J. Gary Booker, MD, APMC	Shreveport	Louisiana
United States	BG Neurology	Spartanburg	South Carolina
United States	Frontier Institute	Spokane	Washington
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Olympian Clinical Research	Tampa	Florida
United States	University of South Florida	Tampa	Florida
United States	VICIS Clinical Research Inc.	Tampa	Florida
United States	Viking Clinical Research	Temecula	California
United States	Compass Research North, LLC	The Villages	Florida
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Oakland Medical Research Site #762	Troy	Michigan
United States	Tulsa Clinical Research, LLC	Tulsa	Oklahoma
United States	New Foundation Medical Group Clinical Trials	Tustin	California
United States	IPC Research	Waukesha	Wisconsin
United States	Neurology Research Institute Palm Beach, LLC #1	West Palm Beach	Florida
United States	Neurology Research Institute Palm Beach, LLC #2	West Palm Beach	Florida
United States	Burke Rehabilitation Hospital	White Plains	New York
United States	Abington Neurological Associates, LTD	Willow Grove	Pennsylvania
United States	Florida Premier Research Institute	Winter Park	Florida
United States	Neuropsychiatric Associates	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  France,  Hungary,  Italy,  Poland,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants using concomitant medications		up to 64 weeks
Primary	Number of Participants with any Treatment-Emergent Adverse Event		up to 64 weeks
Primary	Number of Participants with any Treatment-Emergent Serious Adverse Event		up to 64 weeks
Primary	Number of Participants with any abnormal, clinically significant Clinical Laboratory Value		up to 52 weeks
Primary	Number of Participants with any abnormal, clinically significant 12-lead Electrocardiogram (ECG) value		up to 52 weeks
Primary	Number of Participants with any abnormal, clinically significant Physical and Neurological Examination finding		up to 52 weeks
Primary	Number of participants with any abnormal, clinically significant vital sign value		up to 52 weeks
Primary	Change from Baseline to Week 64 in the Sheehan Suicidality Tracking Scale (S-STS) Score		Baseline; Week 64
Primary	Change from Baseline to Week 52 in the Mini-Mental State Examination (MMSE) Score		Baseline; Week 52
Primary	Change from Baseline to Week 52 in the Epworth Sleepiness Scale (ESS) Score		Baseline; Week 52
Secondary	Change from Baseline to Week 64 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score		Baseline; Week 64
Secondary	Change from Baseline to Week 52 in the Agitation/Aggression, Irritability/Lability, and Aberrant Motor Behavior Domain Scores of the Neuropsychiatric Inventory (NPI)		Baseline; Week 52
Secondary	Change from Baseline to Week 64 in the modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change-Agitation (mADCS-CGIC-Agitation) Score		Baseline; Week 64
Secondary	Change from Baseline to Week 52 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score		Baseline; Week 52
Secondary	Change from Baseline to Week 52 in the Patient Global Impression of Change (PGIC) Score	PGIC (rated by caregiver)	Baseline; Week 52
Secondary	Change from Baseline to Week 52 in the Dementia Quality of Life (DEMQOL) Score		Baseline; Week 52
Secondary	Change from Baseline to Week 52 in the Resource Utilization in Dementia (RUD) Score		Baseline; Week 52
Secondary	Change from Baseline to Week 52 in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) for Participants from Study 17-AVP-786-305		Baseline; Week 52